Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices 22401 

(NCEH), Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

The CDC is requesting OMB approval 

for the EHS–Net National Voluntary 

Environmental Assessment Information 

System (NVEAIS) to collect data from 

foodborne illness outbreak 

environmental assessments routinely 

conducted by local, state, territorial, or 

tribal food safety programs during 

outbreak investigations. Environmental 

assessment data are not currently 

collected at the national level. The data 

reported through this information 

system will provide timely data on the 

causes of outbreaks, including 

environmental factors associated with 

outbreaks, and are essential to 

environmental public health regulators’ 

efforts to respond more effectively to 

outbreaks and prevent future, similar 

outbreaks. This information system is 

specifically designed to link to CDC’s 

existing disease outbreak surveillance 

system (National Outbreak Reporting 

System). 

The information system was 

developed by the Environmental Health 

Specialists Network (EHS–Net), a 

collaborative project of CDC, the U.S. 

Food and Drug Administration (FDA), 

the U.S. Department of Agriculture 

(USDA), and nine states (California, 

Connecticut, Georgia, Iowa, New York, 

Minnesota, Oregon, Rhode Island, and 

Tennessee). The network consists of 

environmental health specialists (EHSs), 

epidemiologists, and laboratorians. The 

EHS–Net has developed a standardized 

protocol for identifying, reporting, and 

analyzing data relevant to foodborne 

illness outbreak environmental 

assessments. 

While conducting environmental 

assessments during outbreak 

investigations is routine for food safety 

program officials, however, reporting 

information from the environmental 

assessments to CDC is not. State, Local, 

Tribal, and Territorial food safety 

program officials are the respondents for 

this data collection—one official from 

each participating program will report 

environmental assessment data on 

outbreaks. These programs are typically 

located in public health or agriculture 

agencies and there are approximately 

3,000 such agencies in the United 

States. Thus, although it is not possible 

to determine how many programs will 

choose to participate, as NVEAIS is 

voluntary, the maximum potential 

number of program respondents is 

approximately 3,000. 

These programs will be reporting data 

on outbreaks, not their programs or 

personnel. It is not possible to 

determine exactly how many outbreaks 

will occur in the future, nor where they 

will occur. However, we can estimate, 

based on existing data that a maximum 

of 1,400 foodborne illness outbreaks 

will occur annually. Only those 

programs in the jurisdictions in which 

these outbreaks occur would report to 

NVEAIS. Thus, not every program will 

respond every year. Consequently, the 

respondent burden estimate is based on 

the number of outbreaks likely to occur 

each year. Assuming each outbreak 

occurs in a different jurisdiction, there 

will be one respondent per outbreak. 

There are two activities associated 

with NVEAIS that require a burden 

estimate. The first is entering all 

requested environmental assessment 

data into NVEAIS. This will be done 

once for each outbreak and will take 

approximately 2 hours per outbreak. 

The second activity is the manager 

interview that will be conducted at each 

establishment associated with an 

outbreak. Most outbreaks are associated 

with only one establishment; however, 

some are associated with multiple 

establishments. We estimate that a 

maximum average of 4 manager 

interviews will be conducted per 

outbreak. Each interview will take about 

20 minutes. 

The total estimated annual burden is 

4,667 hours. There is no cost to the 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Food safety program personnel ....... Reporting environmental assessment data into electronic system.1,400 1 2 2,800 

Food safety program personnel ....... Manager interview ............................ 1,400 4 20/60 1,867 

Total ........................................... ........................................................... ........................ ........................ ........................ 4,667 

Daniel Holcomb, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2011–9670 Filed 4–20–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0231] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Adverse 

Experience Reporting for Licensed 

Biological Products; and General 

Records 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the proposed extension of the collection 

of information concerning requirements 

relating to FDA’s adverse experience 

reporting (AER) for licensed biological 

products, and general records associated 

with the manufacture and distribution 

of biological products. 


emcdonald on DSK2BSOYB1PROD with NOTICES
22402 Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices 

DATES: Submit either written or 

electronic comments on the collection 

of information by June 20, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, Juanmanuel.vilela@ 

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques 

when appropriate, and other forms of 

information technology. 

Adverse Experience Reporting for 

Licensed Biological Products; and 

General Records—21 CFR Part 600 

(OMB Control Number 0910–0308)— 

Extension 

Under the Public Health Service Act 

(42 U.S.C. 262), FDA may only approve 

a biologics license application for a 

biological product that is safe, pure, and 

potent. When a biological product is 

approved and enters the market, the 

product is introduced to a larger patient 

population in settings different from 

clinical trials. New information 

generated during the postmarketing 

period offers further insight into the 

benefits and risks of the product, and 

evaluation of this information is 

important to insure its safe use. FDA 

issued the AER requirements in part 600 

(21 CFR part 600) to enable FDA to take 

actions necessary for the protection of 

the public health in response to reports 

of adverse experiences related to 

licensed biological products. The 

primary purpose of FDA’s AER system 

is to identify potentially serious safety 

problems with licensed biological 

products. Although premarket testing 

discloses a general safety profile of a 

biological product’s comparatively 

common adverse effects, the larger and 

more diverse patient populations 

exposed to the licensed biological 

product provides the opportunity to 

collect information on rare, latent, and 

long-term effects. In addition, 

production and/or distribution 

problems have contaminated biological 

products in the past. AER reports are 

obtained from a variety of sources, 

including manufacturers, patients, 

physicians, foreign regulatory agencies, 

and clinical investigators. Identification 

of new and unexpected safety issues 

through the analysis of the data in the 

AERS system contributes directly to 

increased public health protection. For 

example, evaluation of these safety 

issues enables FDA to take focused 

regulatory action. Such action may 

include, but is not limited to, important 

changes to the product’s labeling (such 

as adding a new warning), coordination 

with manufacturers to ensure adequate 

corrective action is taken, and removal 

of a biological product from the market 

when necessary. 

Section 600.80(c)(1) requires licensed 

manufacturers or any person whose 

name appears on the label of a licensed 

biological product to report each 

adverse experience that is both serious 

and unexpected, whether foreign or 

domestic, as soon as possible but in no 

case later than 15 calendar days of 

initial receipt of the information by the 

licensed manufacturer. These reports 

are known as postmarketing 15-day alert 

reports. This section also requires 

licensed manufacturers to submit any 

followup reports within 15 calendar 

days of receipt of new information or as 

requested by FDA, and if additional 

information is not obtainable to 

maintain records of the unsuccessful 

steps taken to seek additional 

information. In addition, this section 

requires a person who submits an 

adverse action report to the licensed 

manufacturer rather than FDA to 

maintain a record of this action. Section 

600.80(e) requires licensed 

manufacturers to submit a 15-day alert 

report for an adverse experience 

obtained from a postmarketing clinical 

study only if the licensed manufacturer 

concludes that there is a reasonable 

possibility that the product caused the 

adverse experience. Section 600.80(c)(2) 

requires licensed manufacturers to 

report each adverse experience not 

reported in a postmarketing 15-day alert 

report at quarterly intervals, for 3 years 

from the date of issuance of the 

biologics license, and then at annual 

intervals. The majority of these periodic 

reports are submitted annually since a 

large percentage of currently licensed 

biological products have been licensed 

longer than 3 years. Section 600.80(i) 

requires licensed manufacturers to 

maintain for a period of 10 years records 

of all adverse experiences known to the 

licensed manufacturer, including raw 

data and any correspondence relating to 

the adverse experiences. Section 600.81 

requires licensed manufacturers to 

submit, at an interval of every 6 months, 

information about the quantity of the 

product distributed under the biologics 

license, including the quantity 

distributed to distributors. These 

distribution reports provide FDA with 

important information about products 

distributed under biologics licenses, 

including the quantity, certain lot 

numbers, labeled date of expiration, the 

fill lot numbers for the total number of 

dosage units of each strength or potency 

distributed (e.g., fifty thousand per 10- 

milliliter vials), and date of release. FDA 

may require the licensed manufacturer 

to submit distribution reports under this 

section at times other than every 6 

months. Under § 600.90, a licensed 

manufacturer may submit a waiver 

request for any requirements that apply 

to the licensed manufacturer under 

§§ 600.80 and 600.81. A waiver request 

submitted under § 600.90 must include 

supporting documentation. 

Manufacturers of biological products 

for human use must keep records of 

each step in the manufacture and 

distribution of a product including any 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices 22403 

recalls. These recordkeeping 

requirements serve preventative and 

remedial purposes by establishing 

accountability and traceability in the 

manufacture and distribution of 

products. These requirements also 

enable FDA to perform meaningful 

inspections. Section 600.12 requires, 

among other things, that records must 

be made, concurrently with the 

performance of each step in the 

manufacture and distribution of 

products. These records must be 

retained for no less than 5 years after the 

records of manufacture have been 

completed or 6 months after the latest 

expiration date for the individual 

product, whichever represents a later 

date. In addition, under § 600.12, 

manufacturers must maintain records 

relating to the sterilization of equipment 

and supplies, animal necropsy records, 

and records in cases of divided 

manufacturing responsibility with 

respect to a product. Under 

§ 600.12(b)(2), manufacturers are also 

required to maintain complete records 

pertaining to the recall from distribution 

of any product. Furthermore, § 610.18(b) 

requires, in part, that the results of all 

periodic tests for verification of cultures 

and determination of freedom from 

extraneous organisms be recorded and 

maintained. 

Respondents to this collection of 

information include manufacturers of 

biological products and any person 

whose name appears on the label of a 

licensed biological product. Under table 

1 of this document, the number of 

respondents is based on the estimated 

number of manufacturers that are 

subject to those regulations or that 

submitted the required information to 

the Center for Biologics Evaluation and 

Research and Center for Drugs 

Evaluation and Research, FDA, in fiscal 

year (FY) 2010. Based on information 

obtained from the FDA’s database 

system, there were 108 licensed 

biologics manufacturers. This number 

excludes those manufacturers who 

produce Whole Blood or components of 

Whole Blood and in-vitro diagnostic 

licensed products, because of the 

exemption under § 600.80(k). The total 

annual responses are based on the 

number of submissions received by FDA 

in FY 2010. There were an estimated 

86,583 15-day Alert reports, 57,300 

periodic reports, and 349 lot 

distribution reports submitted to FDA. 

The number of 15-day alert reports for 

postmarketing studies under § 600.80(e) 

is included in the total number of 15- 

day alert reports. FDA received 21 

requests for waivers under § 600.90, of 

which 19 were granted. The hours per 

response are based on FDA experience. 

The burden hours required to complete 

the MedWatch Form for § 600.80(c)(1), 

(e), and (f) are reported under OMB 

Control No. 0910–0291. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

600.80(c)(1) and 600.80(e) .................................................. 108 801.69 86,583 1 86,583 

600.80(c)(2) .......................................................................... 108 530.55 57,300 28 1,604,400 

600.81 .................................................................................. 108 3.23 349 1 349 

600.90 .................................................................................. 21 1 21 1 21 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,691,353 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Under table 2 of this document, the 

number of respondents is based on the 

number of manufacturers subject to 

those regulations. Based on information 

obtained from FDA’s database system, 

there were 304 licensed manufacturers 

of biological products in FY 2010. 

However, the number of recordkeepers 

listed for § 600.12(a) through (e) 

excluding (b)(2) is estimated to be 131. 

This number excludes manufacturers of 

blood and blood components because 

their burden hours for recordkeeping 

have been reported under § 606.160 in 

OMB Control No. 0910–0116. The total 

annual records is based on the annual 

average of lots released in FY 2010 

(6,752), number of recalls made (1,881), 

and total number of adverse experience 

reports received (143,883) in FY 2010. 

The hours per record are based on FDA 

experience. 

FDA estimates the burden of this 

recordkeeping as follows: 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per recordkeeping 

(in hours) 

Total hours 

600.12 2 ................................................................................ 131 51.54 6,752 32 216,064 

600.12 (b)(2) ........................................................................ 304 6.19 1,881 24 45,144 

600.80(c)(1) and 600.80(i) ................................................... 108 1,332.25 143,883 1 143,883 

Total .............................................................................. ........................ ........................ ........................ ........................ 405,091 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2The recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12. 


emcdonald on DSK2BSOYB1PROD with NOTICES
22404 Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices 

Dated: April 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9651 Filed 4–20–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0012] 

Analgesic Clinical Trials Innovation, 

Opportunities, and Networks (ACTION) 

Initiative 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of grant funds for the 

support of the Analgesic Clinical Trials 

Innovation, Opportunities, and 

Networks (ACTION) Initiative. The goal 

of the ACTION Initiative is to streamline 

the discovery and development process 

for new analgesic drug products for the 

benefit of public health. The ACTION 

Initiative is being developed, in large 

part, through the establishment of a 

cooperative agreement with one or more 

organizations. The ACTION Initiative 

will address major gaps in scientific 

information, which can slow down 

analgesic clinical trials and analgesic 

drug development. FDA will support 

the ACTION Initiative under the 

authority of the Federal Food, Drug, and 

Cosmetic Act. 

DATES: Important dates are as follows: 

1. The application due date is June 8, 

2011. 

2. The anticipated start date is July 14, 

2011. 

3. The opening date is April 22, 2011. 

4. The expiration date is June 9, 2011. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: Igor 

Cerny, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 3124, Silver Spring, 

MD 20993–0002, 301–796–4273, e-mail: 

Igor.Cerny@fda.hhs.gov; Vieda Hubbard, 

Office of Acquisitions and Grant 

Services, Food and Drug 

Administration, 5630 Fishers Lane 

(HFA–500), Rockville, MD 20857, 301– 

827–7177, e-mail: 

vieda.hubbard@fda.hhs.gov. 

For more information on this funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

refer to the full FOA located at http:// 

grants.nih.gov/grants/guide/ (select the 

‘‘Request for Applications’’ link), 

http://www.grants.gov/ (see ‘‘For 

Applicants’’ section) and/or http:// 

www.fda.gov/AboutFDA/ 

PartnershipsCollaborations/ 

PublicPrivatePartnershipProgram/ 

ucm231130.htm. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

RFA–FD–11–006 

93.103 

A. Background 

Despite the enormous advances in 

drug development over the past 2 or 3 

decades (e.g., drugs that cure cancer and 

biologic drug products that halt the 

progression of rheumatoid arthritis), the 

development of novel analgesic drug 

products has lagged behind. Indeed, to 

this day, the only analgesic drug 

products that are used widely and 

successfully are opioids, 

acetaminophen, and nonsteroidal antiinflammatory agents, all of which have 

serious, potentially life-threatening 

toxicities, even when used properly. 

While there has been exploration at the 

earliest stages of drug development, 

there has been widespread reluctance 

on the part of the pharmaceutical 

industry to take novel products further 

into development. This is in no small 

part due to the often daunting task of 

demonstrating the efficacy of analgesics 

in clinical trials. Many experts in 

analgesic drug development believe that 

it is the design of the clinical trials that 

is at fault in this situation and that 

better trial designs will yield more 

successful results. This hypothesis is 

certainly supported by the frequent 

failures of clinical efficacy trials of 

opioid drug products, considering the 

well established effectiveness of these 

products from literally thousands of 

years of clinical experience. For these 

reasons, additional studies are needed 

to assess the confounding nature of 

analgesic clinical trials and analgesic 

drug development. 

B. Research Objectives 

Based on collaboration with FDA, key 

stakeholder input, best Government, 

academic, and industry practices, and 

knowledge gained through workshops, 

the Grantee will be responsible for 

developing, defining, and 

recommending projects as described in 

this section. Applicants should, at a 

minimum, address the following three 

overarching research domains in this 

section. The overall study design 

processes within each of these domains 

should be aligned with established 

strategic goals and provide results and 

recommendations in alignment with the 

objectives of the ACTION Initiative. 

1. Data analysis of primarily group 

analgesic clinical trials data (databases) 

for relationships between assay 

sensitivity and metrics including, but 

not limited to, specific research designs 

and methodological features so as to 

inform the future design of analgesic 

clinical trials. 

2. Scientific assessment of FDA’s 

clinical trial databases and development 

of novel and alternative means of 

analyzing various pain scores in a 

manner that effectively considers 

variables, such as bias and 

interindividual variance. 

3. Development of methodologies for 

the execution and transformation of 

pooled trial data from multiple relevant 

analgesic trials. 

C. Eligibility Information 

The following organizations/ 

institutions are eligible to apply: 

• Higher education institutions as 

defined in section 101 of the Higher 

Education Act of 1965 (or a consortium 

of such institutions). 

The following types of higher 

education institutions are always 

encouraged to apply for National 

Institutes of Health support as public or 

private institutions of higher education: 

• Hispanic serving institutions. 

• Historically Black colleges and 

universities. 

• Tribally controlled colleges and 

universities. 

• Alaska Native and Native Hawaiian 

serving institutions. 

Nonprofits other than institutions of 

higher education. 

• A nonprofit organization described 

in section 501(c)(3) of the Internal 

Revenue Code of 1986, which is exempt 

from tax under section 501(a) of that 

code. 

An eligible organization that wishes 

to enter into a collaborative agreement 

must provide an assurance that the 

entity will not accept funding for a 

Critical Path Public-Private Partnership 

project from any organization that 

manufactures or distributes products 

regulated by FDA unless the entity 

provides assurances in its agreement 

with FDA that the results of the Critical 

Path Public-Private Partnership project 

will not be influenced by any source of 

funding. 

II. Award Information/Funds Available 

A. Award Amount 

It is anticipated that no more than 

$1 million will be allocated to this 

cooperative agreement. It is anticipated 

that a single award will be made. 


emcdonald on DSK2BSOYB1PROD with NOTICES